Drug Facts

Active ingredients

Titanium Dioxide 15.9%

Purpose

Sunscreen

Uses

helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

shake well before each use

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away

Directions

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. – 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses
Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

DICAPRYLYL CARBONATE, BRASSICA CAMPESTRIS (RAPESEED) OIL *, POLYHYDROXYSTEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE,
PONGAMIA GLABRA SEED OIL, DIETHYL SEBACATE, STEARIC ACID, ALUMINUM HYDROXYDE, HYDROGENATED COCONUT OIL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, SESAMUM INDICUM SEED OIL*, COCOS NUCIFERA OIL, BISABOLOL, TOCOPHEROL, PARFUM.

Questions or comments?

info@biosolis.info or Call Adverse Event Reporting: 1-866-8539427

Package Labeling:

Label

BIOSOLIS SUN SPF50
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61296-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	159 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
KARUM SEED OIL (UNII: 62160PU6FJ)
DIETHYL SEBACATE (UNII: I41B9FJK6V)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SESAME OIL (UNII: QX10HYY4QV)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61296-005-00	1 in 1 BOX	02/01/2019	04/30/2024
1		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2019	04/30/2024

Labeler - Pro Vera SA (375713286)

BIOSOLIS Sun Spray SPF50